Hybrid Clinical Trial Manager – Pharma Sector

Über das Unternehmen

CSL Behring is a global leader in the biotherapeutics industry, driven by its promise to patients. We develop and deliver innovative biotherapies that save and improve the lives of people with rare and serious diseases worldwide. With a significant presence in Marburg, Germany, we are committed to advancing medical research and fostering a collaborative, patient-focused environment. Join our team and contribute to our mission of providing life-changing treatments.

Stellenbeschreibung

We are seeking a highly motivated and experienced Hybrid Clinical Trial Manager to join our dynamic team in Marburg, Hesse. In this critical role, you will be responsible for the end-to-end management of assigned clinical trials, ensuring they are conducted in accordance with ICH-GCP guidelines, regulatory requirements, and CSL Behring’s SOPs. This hybrid position offers the flexibility of both on-site collaboration and remote work, allowing you to effectively lead and oversee trial activities while being an integral part of our Marburg site’s innovative culture. You will manage study timelines, budgets, and resources, collaborating closely with cross-functional teams and external vendors to drive successful trial execution.

Hauptverantwortlichkeiten

• Lead the planning, execution, and close-out of assigned clinical trials, ensuring adherence to project timelines and budget.
• Manage and oversee Contract Research Organizations (CROs) and other third-party vendors, ensuring high-quality performance and deliverables.
• Develop and review clinical study protocols, informed consent forms, CRFs, and other trial-related documents.
• Monitor trial progress, identify potential risks, and implement effective mitigation strategies.
• Ensure all trial activities comply with ICH-GCP, regulatory requirements, and company SOPs.
• Serve as the primary point of contact for internal and external stakeholders regarding trial-related matters.
• Facilitate effective communication and collaboration within the study team and with external partners.
• Participate in the selection, initiation, and ongoing monitoring of clinical trial sites.
• Contribute to the development and implementation of departmental initiatives and process improvements.

Erforderliche Fähigkeiten

• Bachelor's degree in a scientific or health-related field.
• Minimum of 5 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
• In-depth knowledge of ICH-GCP guidelines and relevant regulatory requirements.
• Proven experience in managing CROs and other clinical trial vendors.
• Strong project management skills with the ability to manage multiple priorities and deadlines.
• Excellent communication, leadership, and interpersonal skills.
• Proficiency in English (written and spoken).
• Strong problem-solving and decision-making abilities.

Bevorzugte Qualifikationen

• Master's degree or PhD in a scientific or health-related discipline.
• Experience in specific therapeutic areas such as immunology, hematology, or neurology.
• Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• PMP certification or equivalent project management qualification.
• German language skills (beneficial but not mandatory).

Vorteile & Zusatzleistungen

• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness programs.
• Company pension scheme.
• Generous paid time off and holidays.
• Opportunities for professional development and career advancement.
• Flexible hybrid work model.
• On-site cafeteria and employee support services.
• Modern and collaborative work environment.

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